[WeOaLB0103] Antiretroviral activity and tolerability of Reverset (D-d4FC), a new fluoro-cytidine nucleoside analog when used in combination therapy in treatment-experienced patients: results of phase IIb study RVT-203

3rd International AIDS Society Conference on HIV Pathogenesis and Treatment

Rio de Janeiro - July 24 - 27, 2005

ANTIRETROVIRAL ACTIVITY AND TOLERABILITY OF REVERSET (D-D4FC), A NEW FLUORO-CYTIDINE NUCLEOSIDE ANALOG WHEN USED IN COMBINATION THERAPY IN TREATMENT-EXPERIENCED PATIENTS: RESULTS OF PHASE IIB STUDY RVT-203

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. WeOaLB0103

Cohen C.¹, Katlama C.², Murphy R.³, Gathe J.⁴, Brinson C.⁵, Richmond G.⁶, Girard P.-M⁷, Fessel J.⁸, Liappis A.⁹, Puglia E.¹⁰, Rodwick B.¹¹, Nadler J.¹², O'Brien W.¹³, Arasteh K.¹⁴, Otto M.¹⁵, Erickson-Viitanen S.¹⁶, Levy R.¹⁶
¹Community Research Initiative of New England, Boston, United States, ²Hopital de la Pitie Salpetriere, Paris, France, ³Northwestern University, Chicago, United States, ⁴Fannin St., Houston, United States, ⁵Central Texas Clinical Research, Austin, United States, ⁶315 SE 14th St., Fort Lauderdale, United States, ⁷Hopital St. Antoine, Paris, France, ⁸Kaiser Permanente, San Francisco, United States, ⁹George Washington University Medical Center, Washington, DC, United States, ¹⁰Research Center of Florida, Inc., Miami, United States, ¹¹Clinical Research of West Florida, Clearwater, United States, ¹²Hillsborough County Health Dept., Tampa, United States, ¹³University of Texas Medical Branch, Galveston, United States, ¹⁴EPIMED, Berlin, Germany, ¹⁵Pharmasset, Inc., Tucker, United States, ¹⁶lncyte Corp, Wilmington, United States

OBJECTIVES: Evaluate efficacy and tolerability of once daily doses of 50, 100 or 200 mg Reverset (RVT), a cytidine analog NRTI, in ARV-experienced patients.

METHODS: Phase IIb, randomized, blinded, multinational, placebo-controlled 3 stage study consisting of: 2 wk add-on phase (RVT or placebo); 14-wk optimized treatment phase; and 8-wk safety phase (placebo pts allowed to cross over) in treatment-experienced patients (pts.).

RESULTS: 199 pts enrolled at 25 sites; currently, 120 completed >16 wks of therapy. Mean baseline VL = 4.5 log₁₀, presence of M184V: 60%, M41L: 60%, 4-6 TAMs: 50%, K65R: 6%. After 2 wks, mean VL changed by +0.007, -0.5, -0.3, and -0.7 log₁₀ for placebo, 50, 100, and 200 mg groups respectively. Pts on 200 mg with 0-3 TAMs had 2-wk VL drop of 0.8 log₁₀, with 4-6 TAMs a 0.6 log₁₀ drop. Pts with M41L, M41L+L210W or w/o M41L showed similar VL decreases (0.7 log₁₀). Pts with K65R or M184V + TAMs had more variable responses (mean 0.4 log₁₀ drop); >20% pts had >1 log₁₀ drop. 33% pts didn't optimize at wk 2. Of these, current data shows stable VL decrease of – 0.6 log₁₀ at wk 16 on 200 mg RVT. AEs generally mild, included headache, fatigue and GI disorders. In 35 subjects taking RVT with ddl, 12 (34%) had grade 4 hyperlipasemia, usually occurring after >12 wks of treatment. Among pts not on ddl, asymptomatic grade 4 lipase seen in 5.4% of pts on 200 mg RVT vs. 3.1% on placebo. Pancreatitis seen in 3 pts on RVT+ddI+TDF: 1 pt on ddI 250mg/TDF 450mg, 1 pt on ddI 400mg/TDF 300mg; all resolved off drugs.

CONCLUSIONS: RVT 200 mg is active in ARV-experienced pts and generally well tolerated. Because of the risk of elevated lipase and pancreatitis, RVT should not be used with ddI. Data support continued development of RVT.

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